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Study ID

101468/169

Study Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa

Phase

phase 3

Acronym

Secondary IDs

FDA Regulated Intervention?

Section 801 Clinical Trial

Delayed Posting

IND/IDE Protocol

yes

IND/IDE Grantor

CDER

IND/IDE Number

60,503

IND/IDE Serial Number

0046

Has Expanded Access

no

Study Type

Interventional

Oversight Authority

United States: Food and Drug Administration

Sponsor

GlaxoSmithKline

Collaborators

Brief Summary

The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.

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June 06, 2008

February 21, 2013

Protocol ID

101468/169

Clinical Study ID

101468/169

Official Study Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa